# FDA EIR - Haupt Pharma Latina Srl - June 28, 2018

Source: https://www.keypedia.com/records/eir/haupt-pharma-latina-srl/4187a6b8-4cb0-45a1-8926-b96b3588172d

> FDA EIR for Haupt Pharma Latina Srl on June 28, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: EIR
- Company Name: Haupt Pharma Latina Srl
- Inspection Date: 2018-06-28
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: The FDA conducted a surveillance inspection of Haupt Pharma Latina SrL in Latina, Italy, from June 21 to June 28, 2018. This inspection, focusing on human and veterinary sterile and non-sterile drug manufacturing, was conducted under the regulatory framework of CPGM 7371.001 (Animal Drug Manufacturing) and CPGM 7356.002A (Sterile Drug Process Inspections). The inspection resulted in the issuance of an FDA Form 483 with five observations, highlighting critical issues in the firm's operations.

Main violations included an aseptic processing suite found to be dirty and in a state of disrepair. The firm's media fills did not incorporate worst-case activities to challenge aseptic operations, and its Restricted Access Barrier System (RABS) glove management lacked scientific rationale for usage, integrity testing, and operator qualification. Furthermore, Haupt Pharma Latina did not possess a validated method for neutralizing certain product properties. Assurance was lacking that operators performing visual inspections were adequately trained to detect deficiencies such as particulates, discoloration, or leaks. A recurring issue involved the firm continuing to fill veterinary pharmaceuticals into containers with known integrity concerns for over 1.5 years.

The company's management committed to providing a written response to the FDA's observations within 15 business days. The final regulatory classification for this inspection is currently pending evaluation.

## Related Documents

- [EIR - 2018-06-28](https://www.keypedia.com/records/eir/haupt-pharma-latina-srl/f723b3a7-5690-4af6-b82d-eb30a17ebb4f)
- [EIR - 2018-08-27](https://www.keypedia.com/records/eir/haupt-pharma-latina-srl/ac50166b-5736-4924-b1e8-80ab23ff2a33)

## Related Officers

- [Investigator](https://www.keypedia.com/people/rachael-a-moliver/6130c1d8-9867-4da5-b113-1bbaf0ae9c79)
- [Investigator -Federal Program Manager](https://www.keypedia.com/people/chad-n-thompson/f99444f7-cffb-43d0-b102-315d12115b9e)

Company: https://www.keypedia.com/companies/haupt-pharma-latina-srl/0976ff44-458f-4749-a2d5-3d2728a17a6d

Office: https://www.keypedia.com/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248